Safety and Efficacy of the Tong-Fu-Xing-Shen Herbal Formula for Stroke-Associated Pneumonia

Phase 4

• Conditions: Stroke; Complication
• Interventions: Drug: Tongfu capsules; Drug: The Placebo of Tongfu capsules

• Registration Number: NCT04275219
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Brief Summary

Stroke-associated pneumonia (SAP) is the major complication of acute intracerebral haemorrhage (AICH), leads to poor clinical outcomes and increases the financial burden on the medical system. Prophylactic antibiotics do not reduce the mortality rate of SAP. The Tong-Fu-Xing-Shen herbal formula (TFXS) was shown to be effective for the prevention and treatment SAP in a previous clinical trial. To clarify whether TFXS is effective and safe for the treatment of SAP and affects the immunological mechanism of the "brain-gut-lung" pathway of SAP, the investigators designed this study.

Detailed Description

This is a multicentre, randomized, double-blind, placebo-controlled clinical trial. A total of 218 patients will be recruited and randomly assigned to the experimental group (EG) or the control group (CG) in a 1:1 ratio. The treatment course will be 10-12 consecutive days, with a 90±7-day follow-up. The primary outcome is the all-cause mortality rate and the mortality of pneumonia at the 90±7-day follow-up. Secondary outcomes include changes in the gut microbiota; changes in the NIHSS score, BI index, mRS score, and Stroke-Specific Quality of Life scale (SS-QOL) score; and so on.

Study Timeline

• Study Start: 2019-03-15
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-16
• Study First Posted: 2020-02-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-07
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tong-Fu-Xing-Shen herbal formula	Tongfu capsules	Tong-Fu-Xing-Shen herbal formula prescription (0.4g\*36 capsules/bottle，1-4 capsules each time, three times a day.) for 10-12days.
The Placebo of Tong-Fu-Xing-Shen herbal formula	The Placebo of Tongfu capsules	The Placebo of Tong-Fu-Xing-Shen herbal formula prescription (0.4g\*36 capsules/bottle，1-4 capsules each time, three times a day.) for 10-12 days.

Primary Outcome Measures

Name	Time	Method
the all-cause mortality rate	90±7 days	Any cause of death
the mortality of stroke associated pneumonia	90±7 days	the death of stroke associated pneumonia

Secondary Outcome Measures

Name	Time	Method
Modified rankin scale (mRS)	after drug 10-12 days, 90±7 days	It represents the recovery of neural functions. The scoring ranges from 0 to 5. Scoring 2-5 is defined as disability, which can be divided into 4 grades: mild, moderate, severe and severe.
changes in the gut microbiota between the experiment group and the control group	Baseline (before drug), after drug 10-12 days	gut microbiota is monitored via 16S rRNA gene sequence analysis
National Institute of Health of stroke scale （NIHSS）	Baseline (before drug), after drug 10-12 days, 90±7 days	The NIHSS is for evaluation of neurological deficits. The NIHSS includes the following domains: level of conscious-ness, eye movements, integrity of visual fields, facial movements,arm and leg muscle strength, sensation, coordination, language,speech and neglect. Each impairment is scored on an ordinal scaleranging from 0 to 2, 0 to 3, or 0 to 4. The scoing of it ranges from 0 to 42. The higher scoring represents the more serious nerve defects. The scoring from 0-1 are normal or close to normal, 2-4 are mild, 5-15 are moderate, 6-20 are medium and severe and more than 20 points are severe neurological dysfunction.
Stroke Specific Quality Of Life scale (SS-QOL) (SS-QOL) score	90±7 days	The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke.It consists of 49 items in the 12 domains of energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity (UE) function, vision, and work/productivity.; The score ranges from 0 to 100. The higher the score, the better the quality of life.
Barthel index	Baseline (before drug), after drug 10-12 days, 90±7 days	The score ranges from 0 to 100. It represents the self-care ability. BI index ≤40 defines heavily dependent, ranges from 41 to 60 defines moderate dependent, ranges from 61 to 99 defines mild dependent and 100 defines independent. The scoring ≥\<90 defines life cannot be independent. The percentage of BI 100-90 points in the three groups was statistically followed up by 90ds. The higher scoring represents a better outcome. There are 4 evaluation grades for 10 aspects(complete independence，part of the help, great help, absolutely dependent).The 10 aspects of the BI index includes eating(10,5,0,0), washing(5,0,0,0), making up（5,0,0,0）, dressing up(10,5,0,0），control of the stool(10,5,0,0), control of the urination(10,5,0,0), going to toilet(10,5,0,0), bed-chair transform(15,10,5,0), walking on the ground(15,10,5), going up and down the stairs(10,5,0,0).

Trial Locations

Locations (1)

Guangdong Province Hospital of Tradtional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China